Standardization facilitates plant engineering

Biopharmax set up an insulin manufacturing plant in China. Endress+Hauser provided expertise in Biotech plant applications, instrumentation and a documentation service that complies with USFDA cGMP regulations.

courtesy Biopharmax

Results

Endress+Hauser’s support enabled Biopharmax to build a world-leading plant which by far exceeded expectations

The high-level GMP documentation and certificates assure compliance.

Standardization of instrumentation minimizes installation work and facilitates commissioning, staff training and spare part management.

For over 40 year, Biopharmax has acted as a global design and construction provider of manufacturing facilities and systems, especially in the biopharmaceutical industry.Biopharmax undertakes turnkey projects from URS (User Requirement Specification) and concept stage through implementation to successful validation, including technology transfer. The company's mission is to design, build and validate pharmaceutical facilities of the highest level.

We trusted in the highly qualified and available project service to assure the best fit and quality for each application

Sarel Chen Tov

CEO, Biopharmax

The challenge

The client, a local company in China aimed to manufacture Insulin for the local market. The project's goal was to build a fully automated and monitored facility. Completely reliable instruments play a critical role in achieving this objective and maximizing plant yield and availability. The instrumentation should ensure the best control, high accuracy as well as the lowest possible cost of maintenance and calibration.

Our solution

Endress+Hauser provided the majority of the measurement instruments: All-in-all, more than 350 pieces to measure flow, temperature, pressure, conductivity, chlorine and level. Endress+Hauser's Project team was involved to assure the best fit and quality for each application. We also provided a documentation service that complies with cGMP, EMEA and USFDA validation standards.

An international turnkey project

“It was necessary to transfer technology between two very distant countries around the globe. Meeting this challenge required very tight cooperation between the Biopharmax engineering team and technology providers who understand the most delicate nuances of the process. Using Endress+Hauser’s expertise helped enormously to choose the equipment that best suited to the process and assured the best control, high accuracy, as well as the lowest possible cost of maintenance and calibration.”

Simplification thanks to standardization

“Biopharmax requires instruments from Endress+Hauser in most of its projects — the company’s high reputation means that the client feels safe employing these instruments, which are highly reliable and easy to calibrate. Instrumentation standardization minimizes installation work and facilitates commissioning, staff training and spare part management. Equipment suppliers easily meet project requirements for instrumentation standardization as they used Endress+Hauser instruments to begin with.”

Far beyond expectations

“Biopharmax aimed to build a first class facility with a fully automated plant and processes. Endress+Hauser was our first option. Its reliable and accurate equipment perfectly matched our requirements. The project was completed with significantly higher yield than expected and purity above 99 %. Let me also mention the excellent Endress+Hauser support in building a world-leading plant which by far exceeded our expectations.”